Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

IZL 1981-01-22

TECHNY REX 3000 MOBILE X-RAY UNIT

Applicant Tecnomed, Inc.

K-Number K803103

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GKZ 1981-01-21

ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.

Applicant Abbott Laboratories

K-Number K803219

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ITX 1981-01-21

MARK V DUPLEX ULTRASONIC SCAN SYS.

Applicant Advanced Technology Laboratories, Inc.

K-Number K802438

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KYZ 1981-01-21

IRRIGATION SET W/BULB SYRINGE

Applicant Walpak Co.

K-Number K803200

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FMF 1981-01-21

IRRIGATION PISTON

Applicant Walpak Co.

K-Number K803204

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JOL 1981-01-21

SUCTION PROBE

Applicant Bemis Health Care

K-Number K803206

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CGR 1981-01-21

CORTI-SHURE

Applicant Nuclear Medical Laboratories, Inc.

K-Number K810033

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LCP 1981-01-21

NORMAL AND ELEVATED CONTROL FOR GLYCO.

Applicant Applied Clinical Research Laboratories

K-Number K803186

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N/A 1981-01-21

'NO-BOIL' FOLIC ACID KIT

Applicant Diagnostic Products Corp.

K-Number K810003

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CGI 1981-01-21

IMMUNOREACTIVE ESTRIOL RIA KIT

Applicant Microanalytic Research, Inc.

K-Number K802754

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FPB 1981-01-21

ACRODISC FILTER ASSEMBLY

Applicant Gelman Sciences, Inc.

K-Number K802765

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CEP 1981-01-21

LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT

Applicant Immuno Nuclear Corp.

K-Number K803278

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